Sanitary surveillance: recollection of medications in Brazilian legislation

Abstract

"The article derives from exploratory and transversal research that gathered data on recollection of medications, action foreseen in the Brazilian sanitary legislation that must be adopted by enterprises in cases of registration cancelling or deviation on the quality of products. The study was conducted between March and October 2005, and this article describes its outcomes from four key-cases, which provided elements for discussion by highlighting the kind of procedure adopted in each. Data show that out of 57 recollection cases started in the period, 22 took place voluntarily (38.6%), six due to registration cancelling (10.5%), and 29 by Anvisa’s determination (50.9%). Those 35 featured as non-voluntary (29+6 cases) represented 61.4% of total, regarding which the State was forced to intervene. The discussion uses the principle of beneficence, ethics of protection, responsibility, and the bioethics of intervention. It concludes by indicating that, although there is regulation for voluntary recollection of Revista Bioética 2010; 18(3): 623 – 35 634 medications, this procedure requires responsible intervention by the regulatory agency, aiming at higher good: to benefit and to protect people. It considers that State intervention is ethical in these cases. "